Apparatus And Method For Draining Material From A Stomach

ABSTRACT

This invention relates to new apparatuses for draining material from a stomach and infusing fluid into the stomach comprising a tubing connector, a housing unit, and a one-way valve. In an embodiment the connector can have a first port, a second port, a third port and a branched lumen that extends through each of the first, second and third ports. The housing unit can have a housing lumen that is sized and shaped to receive the third port and the housing unit is sized and shaped to receive the connector. The one-way valve can be sized and shaped to be received in the housing lumen.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/769,243 filed Aug. 20, 2015, which is a National Stage ofInternational Application No. PCT/US2014/017546 filed Feb. 21, 2014,which claims the benefit of U.S. Provisional Application No. 61/768,462,filed Feb. 23, 2013. The entire disclosures of each of these relatedapplications are incorporated by reference herein for all purposes.

TECHNICAL FIELD

The invention generally relates to removal of ingested material from astomach.

BACKGROUND

Obesity is a major health problem in the United States and othercountries. The National Health and Nutrition Examination Survey(1988-1994) reported that approximately 20-25% of Americans are obese,while another study estimated the percentage of overweight Americans tobe between 60% and 65% (Flegal K M, Carroll M D, Ogden C L, Johnson C L“Prevalence and trends in obesity among US adults, 1999-2000” JAMA 2002;288:1723-1727). Obesity can cause numerous health problems, includingdiabetes, degenerative joint disease, hypertension, and heart disease.Weight reduction can be achieved by increased caloric expenditurethrough exercise and/or by reduced caloric consumption through diet.However, in most cases, weight gain often recurs and improvements inrelated co-morbidities are often not sustained.

Surgical procedures present an increasingly common solution for obesepatients. Surgical procedures include, for example, stapledgastroplasty, banded gastroplasty, gastric banding, gastric bypasssurgery, and bilopancreatic bypass. However, these surgical proceduresare invasive, risky and expensive to perform, and many patients regain asubstantial portion of the lost weight.

The use of a gastrostomy to drain a portion of ingested food is analternative to these procedures for weight loss management. Uponinstallation, one end of the gastrostomy tube will reside within thestomach with the other end passing through the abdominal wall outside ofthe body. A low-profile valve which rests against the surface of theskin of the abdomen is typically fitted to the external end of thegastrostomy tube to prevent the inadvertent discharge of the contents ofthe stomach and to prevent inadvertent pulling of the tube inside thestomach.

Typically a fluid, such as water is infused into the stomach to improvethe flow of partially digested material out of the stomach through thegastrostomy tube. While a simple drain tube may be connected to theexternal end of the gastrostomy tube to partially drain the contents ofthe stomach after a meal therefore reducing the amount of food which isdigested, in practice, this simple approach is unsatisfactory. Often,less than the desired portion of the ingested food can be drained beforethe gastrostomy tube clogs with partially digested food. In practice, afluid, typically water, is infused through the discharge end of thegastrostomy tube to clear any clogs and further dilute the contents ofthe stomach so that additional partially digested food may be drained.

Various devices have been used to allow the user to alternately switchbetween draining the stomach, unclogging the gastrostomy tube, ordiluting the contents of the stomach more quickly and efficientlywithout disconnecting the drain tube. However, the devices described inprior art for draining material from the stomach and infusing fluid intothe stomach allow the drained material from the stomach to pass directlythrough the apparatus. This makes it difficult to thoroughly clean themalodorous stomach discharge from the apparatus. It also makes itdifficult to visually identify a clog within the apparatus itself.Additionally, it is desirable that the process of clearing a cloggedgastrostomy tube and diluting the partially digested food can beperformed quickly with little physical exertion. The present inventionis directed to overcoming some of these deficiencies.

SUMMARY

In one embodiment, an apparatus for draining material from a stomach andinfusing fluid into the stomach comprises a connector, a housing unit,and a one-way valve. The connector can have a first port, a second port,a third port and a branched lumen that extends through each of thefirst, second and third ports. The housing unit can have a housing lumenthat is sized and shaped to receive the third port. In some embodiments,the housing unit can further have a slot that is sized and shaped toreceive the connector. The one-way valve can be sized and shaped to bereceived in the housing lumen.

In another embodiment, an apparatus for draining material from a stomachand infusing fluid into the stomach comprises a tubing set, a fluidreservoir, and a housing unit to connect the fluid reservoir to thetubing set. The tubing set includes a connector that has three ports anda branched lumen which connects all of the ports. The fluid reservoirconsists of a deformable container which when squeezed ejects fluid fromthe reservoir. The housing has a housing lumen which connects the thirdport of the connector to the fluid container through a one-way valve anda means to occlude the fluid flow out of the first fluid port of theconnector.

Methods of assembling an apparatus for draining material from a stomachand infusing fluid into the stomach are also disclosed. In oneembodiment a connector is removed from a housing unit, the connectordefining a first port, a second port, and a branched lumen, and thehousing unit defining a housing lumen. A first tube can be connected tothe first port and a second tube can be connected to the second port.The connector assembly can then be fit into the housing unit such thatthe housing lumen and branched lumen together form a fluid conduit, andan interface between the housing unit and the connector forms a fluidtight seal.

Methods of cleaning an apparatus for draining material from a stomachare also disclosed. In one embodiment a connector can be engaged to ahousing unit. The connector can define a first port, a second port, athird port and a branched lumen. The branched lumen can have a first armthat extends through the first port, a second arm that extends throughthe second port and a third arm that extends through the third port. Thehousing unit can define a housing lumen; wherein the engaging causes thebranched lumen and the housing lumen together to form a fluid conduitand causes an interface between the housing unit and the connector toform a fluid tight seal. A first tube can be occluded, the first tubedefining a first tube lumen. The first tube can be engaged to the firstport of the connector and the first tube lumen and the branched lumentogether can form a first fluid path. A fluid reservoir having an outletand containing a fluid can be engaged to the housing unit such that theoutlet and housing lumen together form a reservoir fluid pathway. Afirst pressure can be exerted on the fluid reservoir, causing fluid toflow from the fluid reservoir and through the conduit. The occlusion canbe removed from the first tube. A second pressure can be exerted on thefluid reservoir, wherein the second pressure on the fluid reservoircauses fluid to flow from the fluid reservoir, and through the outlet,the reservoir fluid pathway, the fluid conduit and the first tube.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed descriptionwill be better understood when read in conjunction with the appendeddrawings. For the purpose of illustrating the subject matter, there areshown in the drawings exemplary embodiments of the subject matter;however, the presently disclosed subject matter is not limited to thespecific methods, devices, and systems disclosed. In addition, thedrawings are not necessarily drawn to scale. In the drawings:

FIG. 1A is a perspective view of an apparatus for draining material froma stomach in relation to a skin port.

FIG. 1B is a perspective view of the apparatus for draining materialfrom a stomach connected to a skin port.

FIG. 2A is a perspective view of a connector element of an apparatus fordraining material from a stomach.

FIG. 2B is a perspective view of a connector element shown in FIG. 2A,the connector element having first and second tubes attached to thefirst and second ports.

FIG. 3 is a cross-section view of an apparatus for draining materialfrom a stomach.

FIG. 4 is a perspective view of elements of an apparatus for drainingmaterial from a stomach according to one embodiment.

FIG. 5A is a perspective view of an apparatus for draining material froma stomach showing the connector engaged to the housing unit.

FIG. 5B is a perspective view of the apparatus for draining materialfrom a stomach showing the fluid reservoir engaged to the housing unit.

FIG. 5C is a perspective view of the apparatus for draining materialfrom a stomach showing a clamp for occluding the first tube in anunclamped position.

DETAILED DESCRIPTION

The present invention may be understood more readily by reference to thefollowing description taken in connection with the accompanying Figuresand Examples, all of which form a part of this disclosure. It is to beunderstood that this invention is not limited to the specific products,methods, conditions or parameters described and/or shown herein, andthat the terminology used herein is for the purpose of describingparticular embodiments by way of example only and is not intended to belimiting of any claimed invention. Similarly, unless specificallyotherwise stated, any description as to a possible mechanism or mode ofaction or reason for improvement is meant to be illustrative only, andthe invention herein is not to be constrained by the correctness orincorrectness of any such suggested mechanism or mode of action orreason for improvement. Throughout this text, it is recognized that thedescriptions refer both to the features and methods of making and usingapparatuses for removal of material from a stomach, as well as theapparatuses themselves, and vice versa.

In the present disclosure the singular forms “a,” “an,” and “the”include the plural reference, and reference to a particular numericalvalue includes at least that particular value, unless the contextclearly indicates otherwise. Thus, for example, a reference to “amaterial” is a reference to at least one of such materials andequivalents thereof known to those skilled in the art, and so forth.

When a value is expressed as an approximation by use of the descriptor“about,” it will be understood that the particular value forms anotherembodiment. In general, use of the term “about” indicates approximationsthat can vary depending on the desired properties sought to be obtainedby the disclosed subject matter and is to be interpreted in the specificcontext in which it is used, based on its function. The person skilledin the art will be able to interpret this as a matter of routine. Insome cases, the number of significant figures used for a particularvalue may be one non-limiting method of determining the extent of theword “about.” In other cases, the gradations used in a series of valuesmay be used to determine the intended range available to the term“about” for each value. Where present, all ranges are inclusive andcombinable. That is, references to values stated in ranges include everyvalue within that range.

It is to be appreciated that certain features of the invention whichare, for clarity, described herein in the context of separateembodiments, may also be provided in combination in a single embodiment.That is, unless obviously incompatible or specifically excluded, eachindividual embodiment is deemed to be combinable with any otherembodiment(s) and such a combination is considered to be anotherembodiment. Conversely, various features of the invention that are, forbrevity, described in the context of a single embodiment, may also beprovided separately or in any sub-combination. It is further noted thatthe claims may be drafted to exclude any optional element. As such, thisstatement is intended to serve as antecedent basis for use of suchexclusive terminology as “solely,” “only” and the like in connectionwith the recitation of claim elements, or use of a “negative”limitation. Finally, while an embodiment may be described as part of aseries of steps or part of a more general structure, each said step mayalso be considered an independent embodiment in itself.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are described herein.

Referring to FIGS. 1A-1B, an apparatus 100 is configured to align with agastrostomy tube 305 such that when the gastrostomy tube is positionedin the stomach of a patient, ingested material (semi-digested food,fluid, etc.) can drain from the stomach through the gastrostomy tube 305and through the apparatus 100. As shown in FIGS. 1A and 1B, theapparatus 100 can comprise a first tube 204 and a second tube 203. Thesecond tube 203 can be attached to a skin port connector 315 that can bedesigned to mate with a skin port 310; in some embodiments the skin portconnector 315 can be locked onto the skin port 310. When the skin portconnector 315 is attached and locked to skin port 310, a fluid path isformed by the gastrostomy tube 305 and the apparatus 100, includingtubes 203 and 204. The apparatus 100 can include a fluid reservoir 500for infusing fluid into the stomach through the fluid path or forrinsing the first tube 204 or the second tube 203. The fluid reservoiritself may comprise a hollow body 502 and a reservoir connector 501—see,e.g., FIG. 5B).

It should be appreciated that the term “fluid” as used herein, whilegenerally referring to liquids, such as water, in some circumstancesalso includes air or other gaseous or vaporous materials. It is expectedthat, at times, people may squeeze air from the reservoir to clearclogs, particularly when they are in a hurry and do not want to take thetime to fill the reservoir with water. Such embodiments fall within thescope of the present invention.

Referring now to FIGS. 2-5, the apparatus 100 can include a connector201, a housing unit 115 (also referred to herein as “companion” or“companion body,” in FIGS. 3-5) and a one way valve 103 (FIG. 3). Theconnector 201 can have a plurality of ports, such as a first port 205, asecond port 210, and a third port 215 (see especially FIG. 2B). Theconnector 201 can comprise a lumen, such as a branched lumen 220 (FIG.3). Such a branched lumen 220 can extend through each of the pluralityof ports, such as the first 205, second 210, and third ports 215. Theconnector 201 can have a T-shape, for example where the first port 205and second port 210 are aligned substantially along a common axis andthe third port 215 is aligned perpendicular to and positioned betweenthe first port 205 and second port 210 and can therefore be referred toas a Tee Fitting. While described here as a T-shaped connector this isbut one embodiment of the connector. The shape of the connector 201 isnot necessarily required to have the axes of the ports aligned orperpendicular to each other as long as the ports share a common branchedlumen. Accordingly, “Y-shape” configuration may also be employed. Thehousing unit 115 can have a housing lumen 120. The housing lumen 120(FIG. 3) can be straight, curved, angled, branched or any otherconfiguration. The housing lumen 120 can extend through the housing unitsuch that it forms a reservoir inlet 130 and a connector inlet 135 (FIG.3). The housing unit 115 can also have a slot 125 that is sized andshaped to receive the connector 201. The housing lumen 120 can be sizedand shaped to receive the third port 215 of the connector 201. Theconnector 201 can engage with the housing unit 115 (FIGS. 3-5) so thatpart or all of the third port 215 fits within the housing lumen 120(FIG. 3). In some embodiments the slot 125 and connector 201 aredesigned so that the connector 201 will only fit in the slot 125 (FIG.5B) in a particular, pre-selected orientation. This feature can beadvantageous if the tubing connected to the first port and second portare of different sizes, wall thicknesses, or materials. For example, thetube connected to the second port may be a more kink-resistant,thick-walled silicone rubber tube than the tube connected to the secondport which undergoes less bending during use. While the one-way valve103 is generally described herein as an umbrella valve, this is but oneembodiment, and the valve can be any type of valve that permits the flowof fluid in one direction and prevents the flow of fluid in the oppositedirection, such as a trumpet valve, a ball valve, a duck-bill valve, oran umbrella valve. The one-way valve 103 (FIG. 4) can be sized andshaped to fit within the housing lumen. In some embodiments the one wayvalve is positioned to permit fluid to flow in the direction from thereservoir inlet 130 toward the connector inlet 135 and to prevent fluidfrom flowing in the direction from the connector inlet 135 to thereservoir inlet 130 (FIG. 3). Preferably, the one-way valve ispositioned to permit fluid to flow in the direction from the reservoirinlet 130 toward the connector inlet 135 thereby allowing fluid to flowfrom the fluid reservoir 502 through the second tube 203 into thepatient's stomach, or from the fluid reservoir 502 through both thefirst tube 504 and the second tube 203 for clearing obstructions orcleaning. Positioning the one-way valve so that fluid cannot flow fromthe connector inlet 135 toward the reservoir inlet will also preventmaterial that is drained from the stomach from passing from the secondtube 203 to the fluid reservoir 502.

Referring to FIGS. 2A/B, 3, and 5A, the apparatus can include a firsttube 204 having a first tube lumen 225 that is sized and shaped toconnect to the first port 205. The first tube 204 can connect to thefirst port 205 by receiving the first port 205 in the first tube lumen225 (see FIGS. 2A/B). Alternatively the first port 205 can receive thefirst tube lumen 225 in the branched lumen 220 extending through thefirst port 205. When the first tube 204 is connected to the first port205 the first tube lumen 225 and the branched lumen 220 form a conduitthrough which fluid can pass. The apparatus can also include a secondtube 203 having a second tube lumen 230 that is sized and shaped toconnect to the second port 210. The second tube 203 can connect to thesecond port 210 by receiving the second port 210 in the second tubelumen 230. Alternatively the second port 210 can receive the second tubelumen 230 in the branched lumen 220 extending through the second port210. When the second tube 203 is connected to the second port 210 thesecond tube lumen 230 and the branched lumen 220 form a conduit throughwhich fluid can pass.

Referring now to FIGS. 3, 4, and 5A-C, the housing unit 115 can becomprised of a back housing 101 and a front housing 102. The housingunit 115 can also include one or more tubular fittings, such as elbowfitting 105, which together with the back housing 101 and the fronthousing 102 define lumen 120. The housing unit can further comprise oneor more gaskets, such as O-rings 104 and 106, which can be made of anelastomeric material and can form a fluid tight seal between individualelements of the housing unit. Alternatively the housing unit 115 can bemade of a single element having a lumen therein.

Some embodiments contain as fixture within the back housing 101 ontowhich a lanyard 610 or neckstrap may be fastened. The incorporation ofsuch a lanyard/neck strap is important for the ease of use of thedevice, since it supports the apparatus during therapy, thus freeing upboth hands of the patient to manipulate the device. In preferredembodiments, the device is designed to make it easy for the lanyard tobe removed for cleaning purposes.

Still referring to FIG. 4, the apparatus 100 can further comprise afluid reservoir 500 for holding a fluid. The fluid reservoir 500 canhave a hollow body 502, for example a bag or a bottle. The reservoirbody 502 can be made of a flexible material. In some embodiments thereservoir body 502 is constructed of two layers of welded flexible film.The reservoir body 502 can then be flattened and folded or rolled whennot in use. The fluid reservoir 500 can also have a reservoir connector501 for engaging the housing unit 115. The reservoir connector 501 canbe permanently affixed to the reservoir body 502 or can be detachablefrom the reservoir body 502. The reservoir connector 501 can include agroove, threading, lip, or other structure capable of engaging thehousing unit 115. In other embodiments, the reservoir comprises abottle, or other reservoir body, with an accompanying pump that iscapable of forcing air out of the reservoir.

As shown in FIG. 4, the housing unit 115 can include a reservoir lockingdevice for holding a fluid reservoir 500 to the housing unit 115, forexample by spring-tension. In an embodiment, a reservoir locking devicecan include a reservoir release 107. The reservoir release 107 canengage a groove or a lip on the reservoir connector 501. The reservoirlocking device can also include a reservoir release spring 108 that canexert a biasing force on the reservoir release 107. The reservoir 500can be locked to the reservoir release 107 by pushing the reservoirconnector 501 into the lumen 120 of housing unit 115 until the reservoir500 is positioned such that the reservoir release spring 108 pushes thereservoir release 107 into a groove on the reservoir connector 501. Thereservoir 500 can be released by simultaneously disengaging thereservoir release 107 from the reservoir connector 501 and pulling thereservoir away from the housing unit 115. The reservoir release 107 canbe disengaged from the reservoir connector 501, for example, by having aportion of the reservoir release 107 at the opposite end of thereservoir release 107 from the reservoir release spring 108, or a buttonconnected to the reservoir release 107 or the reservoir release spring108, accessible from the outside of the housing unit 115 so thatdepression of the button or reservoir release 107 compresses thereservoir release spring 108 and disengages the reservoir release 107from the reservoir connector 501. FIG. 5B illustrates an embodimentwhere the reservoir 500 is engaged with the housing unit 115. The solidarrow indicates that the reservoir release button will extend away fromthe housing unit 115 and the reservoir release 107 will snap into lockedposition when the reservoir connector 501 reaches the proper engagementdepth.

The housing unit 115 can include a locking device that can hold theconnector 201 to the housing unit 115, such as by spring-tension. Insome embodiments, the locking device can be made of a connector release110 and connector release spring 109. As the connector 201 is pushedinto the slot 125, the connector 201 can deflect the connector releasespring 109 until the connector 201 is fully engaged with the housingunit 115 and the connector release spring 109 holds the connector 201 inplace. The connector 201 can be removed from the housing unit 115 bysimultaneously depressing a button (such as a rocker) connected to theconnector release spring 109 and pulling the connector 201 away from thehousing unit 115. FIG. 5A illustrates the connector 201 positioned inslot 125 of housing unit 115 but not fully engaged with the housing unit115. The solid arrow indicates that connector 201 can be fully engagedwith the housing unit 115 and locked in place by pushing the connector201 until the connector release 110 deflects and continuing to push theconnector 201 until it snaps into the locked position.

As shown in FIGS. 1, 3, and 5A-B, the apparatus 100 can also include aclamp 112 for occluding the first tube lumen 225. FIG. 5C illustrates anembodiment of apparatus 100 including a clamp 112, where the clamp 112is in an open position and not occluding the first tube lumen 225. Thesolid arrow indicates that the clamp 112 can be rotated until it is in alocked position, indicating that the first tube lumen 225 is occluded.It may be desirable to lock the drain clamp 112 and so close the fluidpath through the first tube 204 in order to direct fluid from the fluidreservoir into the second tube 203 and into the stomach. It may also bedesirable to lock the drain claim 112 and so close the fluid paththrough the first tube 204 in order to direct fluid from the fluidreservoir into the second tube 203 to rinse the second tube 203 after ithas been used to drain material from the stomach.

In an illustrative embodiment, and with reference to FIG. 4, anapparatus 100 can have Drain Tube (204) and Connector Tube (203)connected via a removable 3-way Tee Connector (201). The third port 215of Tee Connector (201) can connect to a bore 120 in the Companion body115 with an O-ring seal 202. When the Tee Connector (201) is attached tothe Companion body 115, Tee Connector Release (110) can be used tosecure it to the Companion body 115. At the other end of the bore 120 inthe Companion body 115 there can be an Umbrella Valve (103). An UmbrellaValve (103) is a one-way check valve, which can be mounted on a surfacethrough a small hole, which also can have additional openings located atstrategic areas within, for example under the dome of, the profile ofthe Umbrella Valve (103) for allowing fluids to flow into the adjacentchamber. The design of the Umbrella Valve (103) is a thin circular domeor umbrella-like shape that seals against fluid flow in one directionand lets fluid pass through the other direction with a very low crackingpressure. The opening on the other side of the Umbrella Valve (103) canbe connected to the Reservoir (500) via an Elbow Fitting (105). TheReservoir (500) can connect to the Companion body 115 by means of aneasily detachable reservoir Connector (501). An O-ring mounted to theElbow Fitting (105) can create a seal between the Reservoir Connector(501) and Elbow Fitting (105) when connected. When the Reservoir (500)is squeezed it can create a pressure in excess of the cracking pressureof the Umbrella Valve (103) which results in water flow through the bore120 of the Companion body 115, into the Tee Connector (201) and beyond.The slot 125 can include channels on the either side of the TeeConnector (201) for Drain Tube (204) and the Connector Tube (203) torest within the profile of the Companion body 115. There is an L-shapedDrain Clamp (112) for clamping and occluding Drain Tube (204).

Referring now to FIG. 1, The skin port connector (315) can be located atthe distal end of the Connector Tube (203), that is, the end of thesecond tube (203) nearest the body of the patient. The distal end of theConnector Tube (203) can be connected to the gastrostomy tube (305)through Skin Port Valve and Skin Port Flange (310).

Advantages of the various features of the present invention can beunderstood with reference to FIGS. 2-4. Apparatuses of the invention canbe smaller and lighter than previous designs. In an embodiment of theinvention, an apparatus can use an Umbrella Valve (103) instead ofduckbill valve as a one-way check valve. In this design, an UmbrellaValve (103) can provide better features than the duckbill valve in thefollowing areas: (1) better flow rate for infusion of water while notallowing any flow in the reverse direction, thus, reducing infusiontime; (2) infusion requires less effort by the patient in exertingpressure on the reservoir bag (502); (3) faster infusion enables bettercleaning the fluid paths; (4) faster fluid flow reduces possibility ofocclusion and (5) it is easier to clean partially-digested foodparticles from the domed surface of the umbrella valve without damagingthe seal. Designs of the invention employ a simplified fluid path thatcan be easily disassembled and reassembled by the patient for cleaningand maintenance purposes. Design of the invention enables the patient toremove the Tee Fitting sub-assembly (200) with associated tubing (203,204) from main structure of device (115). The Tee Fitting sub-assembly(200) can be further dissembled by detaching drain (204) and connectortubes (203) from barb connections (205, 210) of Tee Fitting. Theconnector may also be molded from a transparent, tinted, or translucentplastic to allow the user to visually inspect the branched lumen withinthe connector. Therefore, in designs of the invention, no semi-digestedfood can remain inside the device that cannot easily be noticed,enabling thorough cleaning of the device after the procedure, andpreventing the possibility of generating foul odor. An additionaladvantage of the present invention having a removable connector 201 isthat the Tee Connector (201) can be keyed to the housing body 115 toprevent reverse installation of Connector Tube (203) and Drain Tube(204) orientations. In an alternative embodiment, the entire Tee-fittingtubing sub-assembly may be supplied as a pre-assembled disposable. Thisis particularly advantageous for situations such as dining out, where itmay be inconvenient to clean the tubing set. This would also allow lessexpensive, lower durable materials to be used for the tubing andconnector. A push-to-connect Reservoir (500) attachment system is easierto use and does not require radial alignment of Reservoir Connector(501) to housing 115 to engage locking mechanism. A single buttonrelease feature may be used to un-lock the Reservoir (500) from housing115. The Reservoir (500) is constructed of two layers of welded flexiblefilm which, when empty, can be flattened and rolled up, requiringminimum space for storage between uses. Such a Reservoir (500) is moredurable since it can be manufactured from a stronger and thickermaterial. The Reservoir Connector (501) can be welded to the film of theReservoir Bag (502).

The apparatus can be assembled before aspiration therapy, or drainingingested material from a patient's stomach and infusing fluid into thestomach. First the Tee Connector (201) is removed from housing 115. TheConnector Tube (203) is attached to the proper barbed fitting (210) ofthe Tee Connector (201). Connect Drain Tube (204) to the proper barbfitting (205) of the Tee Connector (201). The Tee Connector (201) isinserted into the housing 115, making sure O-ring is in place and nottwisted and the Tee Connector (201) is secured by the Tee ConnectorRelease (110). The Drain Clamp (112) is rotated closed to occlude DrainTube (204). After filling the Reservoir (500) with water, it isconnected to the bottle connector or reservoir locking device by pushingup until it snaps in place. The skin port connector 315 is connected tothe Skin Port Valve 310 of the patient and latched by pushing the leveron the skin port Connector 315 until a click is heard, confirming it isproperly connected. The patient is then ready for the aspirationtherapy.

Apparatuses of the invention can be used to perform aspiration therapy,and methods of assembling an apparatus for draining material from astomach and infusing fluid into the stomach are also considered withinthe scope of the present invention. In one embodiment a connector isremoved from a housing unit, the connector defining a first port, asecond port, and a branched lumen, and the housing unit defining ahousing lumen. A first tube can be connected to the first port and asecond tube can be connected to the second port. The connector assemblycan then be fit into the housing unit such that the housing lumen andbranched lumen together form a fluid conduit, and an interface betweenthe housing unit and the connector forms a fluid tight seal. While it issomewhat easier to attach the tubing with the connector out of thehousing, the tubing can be attached regardless of whether the connectoris inserted in the housing or removed. Regardless, this isn'tnecessarily an advantage. What is advantageous is that the tubing setwith the connector can be treated as a single unit. The user willtypically keep this tubing set assembled and ready to use or clean it asa unit.

When used for aspiration therapy, the housing 115 connects to thegastrostomy tube 305 via the skin port Connector 315 and the Skin Portvalve 310. It provides a passage for aspiration of the semi-digestedfood out of the patient's stomach. It provides the means for infusingwater into the patient's stomach to improve aspiration. It provides asimpler way of cleaning the housing 115 and associated connector 201 andtubing 203, 204 after the procedure.

The following is an example method of aspiration: After the assembledapparatus is connected to the patient through a skin port connector 315,the Drain Tube (204) can be placed over a toilet, bucket, or otherremoval system for discharging aspirated semi-digested food and fluidfrom the patient. Unclamping the Drain Tube (204) by releasing the DrainClamp (112) starts aspiration. Semi-digested food can flow bygravitation and siphon from the gastrostomy tube 305, through the SkinPort valve, and the skin port connector 315 into the Connector Tube(203). Then it can flow into the Tee Connector (201). The Umbrella checkvalve (103) downstream of the third port 215, does not allow the fluidto pass through into the Reservoir (500). The aspirating semi-digestedfood can only flow into the Drain Tube (204) for discharge into thetoilet.

The addition of water into the stomach can increase the pressure insidethe stomach and dilute the contents within the stomach of the patientand improve aspiration. This can be done if and when aspiration stopseven when connected to the apparatus 100 with Drain Tube (204) open. Thefollowing is an example procedure for infusing water: Occlude the DrainTube (204), for example, by clamping using the Drain Clamp (112). Thisblocks the infusing water from flowing into the Drain Tube (204).Squeezing the Reservoir (500) creates pressure forcing water to flow outof the Reservoir, past the Umbrella valve and into the third port of theconnector. Since the drain tube is occluded by the Drain Clamp, thewater is forced through the second port into the Connector Tube (203),gastrostomy tube (305) and into the stomach clearing any clogs by theforce of the water pressure. This additional volume of water in thepatient's stomach increases the pressure inside the patient's stomach torestart aspiration.

Methods of cleaning an apparatus for draining material from a stomachare also disclosed. In one embodiment a connector can be engaged to ahousing unit. The connector can define a first port, a second port, athird port and a branched lumen. The branched lumen can have a first armthat extends through the first port, a second arm that extends throughthe second port and a third arm that extends through the third port. Thehousing unit can define a housing lumen; wherein the engaging causes thebranched lumen and the housing lumen together to form a fluid conduitand causes an interface between the housing unit and the connector toform a fluid tight seal. A first tube can be occluded, the first tubedefining a first tube lumen. The first tube can be engaged to the firstport of the connector and the first tube lumen and the branched lumentogether can form a first fluid path. A fluid reservoir having an outletand containing a fluid can be engaged to the housing unit such that theoutlet and housing lumen together form a reservoir fluid pathway. Afirst pressure can be exerted on the fluid reservoir, causing fluid toflow from the fluid reservoir and through the conduit. The occlusion canbe removed from the first tube. A second pressure can be exerted on thefluid reservoir, wherein the second pressure on the fluid reservoircauses fluid to flow from the fluid reservoir, and through the outlet,the reservoir fluid pathway, the fluid conduit and the first tube.

The following is a method for cleaning the apparatus 100 after theprocedure is over: Remove the apparatus 100 from the patient byreleasing the skin port Connector 315 from the Skin Port valve 310.Occlude the Drain Tube 204, such as by closing the Drain claim 112.Squeezing the Reservoir 500 forces water through the Umbrella Valve 103into the Tee Connector 201. Since the Drain Tube 204 is clamped, waterwill flow through the Tee Connector 201 cleaning the skin port connector315, the Connector Tube 203 and part of the Tee Connector 201. Next,occlude the Connector Tube 203 by blocking the Connector port 210 or bypinching the Connector Tube 203 closed. Unclamp the Drain Tube 204 byreleasing the Drain Clamp 112. Squeeze the Reservoir 500 to force waterthrough the Umbrella Valve 103 into the Tee Connector 201. Since, thewater cannot flow through the occluded Connector Tube 203; it will flowthrough the Drain Tube 204 to discharge into the toilet. This willremove any food particles from the Drain Tube 204 and part of the TeeConnector 201.

It is to be understood that while the invention has been described inconjunction with the preferred specific embodiments thereof, that theforegoing description and the examples that follow are intended toillustrate and not limit the scope of the invention. It will beunderstood by those skilled in the art that various changes may be madeand equivalents may be substituted without departing from the scope ofthe invention, and further that other aspects, advantages andmodifications will be apparent to those skilled in the art to which theinvention pertains. In addition to the embodiments described herein, thepresent invention contemplates and claims those inventions resultingfrom the combination of features of the invention cited herein and thoseof the cited prior art references which complement the features of thepresent invention. Similarly, it will be appreciated that any describedmaterial, feature, or article may be used in combination with any othermaterial, feature, or article, and such combinations are consideredwithin the scope of this invention.

What is claimed:
 1. An apparatus (100) comprising: (i) a housing unit(115) comprising a back housing (101) and a front housing (102), saidhousing unit (115) having a housing lumen (120) extending through thehousing unit so as to form a reservoir inlet (130) and a connector inlet(135), and said front housing (102) having a slot (125); the housingunit further comprising a spring-tensioned connector locking device, thelocking device comprising a connector release (110) and a connectorrelease spring (109); (ii) a removable tubing connector (201) engaged inthe slot (125) of the front housing (102) and held in place by theconnector release spring (109); (iii) a one-way valve (103) that issized and shaped to be received in the housing lumen (120); and (iv) anoptional fluid reservoir (500); wherein the removable tubing connector(201) comprises a first port (205), a second port (210), and a thirdport (215), said connector (201) further comprising a branched lumen(220) having a first arm that extends through the first port (205), asecond arm that extends through the second port (210), and a third armthat extends through the third port (215); wherein said slot (125) issized and shaped to reversibly engage the removable tubing connector(201) only in a preselected orientation and wherein said housing lumen(120) is sized and shaped to receive the third port (215) of theremovable tubing connector (201) into the connector inlet (135); whereinthe one-way valve is directionally positioned to permit fluid to flow inthe direction from the reservoir inlet (130) toward the connector inlet135 and to prevent fluid from flowing in the direction from theconnector inlet (135) to the reservoir inlet (130); and wherein thefluid reservoir (500), when present, is in fluid communication with thereservoir inlet (130).
 2. An assembly comprising: the apparatus (100) ofclaim 1, and one or more of a first tube (204) having a first lumen(225) and a second tube (203) having a second lumen (230); wherein thefirst tube (204), when present, is connected to and in fluidcommunication with the first port (205); and the second tube (203), whenpresent, is connected to and in fluid communication with the second port(210).
 3. The assembly according to claim 2, wherein both the first tube(204) and the second tube (203) are present, and connected to and influid communication with the first port (205) and second port (210),respectively, and the third port (215) of the removable tubing connector(201) is engaged in the connector inlet (135).
 4. The assembly accordingto claim 2, comprising the second tube (203) connected to and in fluidcommunication with the second port (210), wherein the second tube isfurther in fluid communication with a gastrostomy tube (305).
 5. Theassembly according to claim 3, wherein the second tube (203) is furtherin fluid communication with a gastrostomy tube (305).
 6. The assemblyaccording to claim 4, wherein the gastrostomy tube (305) furthercomprises a skin port valve (310), and the second tube (203) furthercomprises a skin port connector (315) configured to mate with the skinport valve (310) to allow fluid communication between the gastrostomytube (305) and the second tube (203).
 7. The assembly according to claim5, wherein the gastrostomy tube (305) further comprises a skin portvalve (310), and the second tube (203) further comprises a skin portconnector (315) configured to mate with the skin port valve (310) toallow fluid communication between the gastrostomy tube (305) and thesecond tube (203).
 8. The apparatus according to claim 2, furthercomprising a clamp (112) for occluding the first tube lumen (225). 9.The assembly according to claim 2, further comprising the fluidreservoir (500) in fluid communication with the reservoir inlet (130).10. The assembly according to claim 9, wherein the fluid reservoir (500)comprises a fluid reservoir locking device for holding the fluidreservoir (500) in fluid communication with the housing lumen (120) ofthe housing unit (115) by spring tension, wherein the reservoir lockingdevice includes a reservoir release (107) for engaging a groove or a lipon a reservoir connector (501) of the fluid reservoir (500).
 11. Theassembly according to claim 10, wherein the fluid reservoir (500)further comprises a hollow body (502).
 12. The assembly according toclaim 11, wherein the hollow body (502) comprises a flexible material.13. The assembly according to claim 2, the one-way valve (103) being atrumpet valve, a ball valve, a duck-bill valve, or an umbrella valve.14. The apparatus according to claim 2, the removable tubing connector(201) defining a T-shape or a Y-shape.
 15. The assembly according toclaim 2, comprising: (a) the second tube (203) comprising a skin portconnector (315) configured to mate with a skin port (310) of agastrostomy tube (305); (b) a clamp (112) for occluding the first tubelumen (225); (c) the fluid reservoir (500), optionally comprising aflexible reservoir bag (502), in fluid communication with the reservoirinlet (130), the fluid reservoir (500) further comprising a fluidreservoir locking device for holding the fluid reservoir (500) in fluidcommunication with the housing lumen (120) of the housing unit (115) byspring tension, wherein the reservoir locking device includes areservoir release (107) for engaging a groove or a lip on a reservoirconnector (501) of the fluid reservoir (500).
 16. The assembly accordingto claim 15, further comprising the gastrostomy tube (305), connected bythe mating of the skin port connector (315) of the second tube (203)with the skin port valve (310) of the gastrostomy tube (305).
 17. Amethod for draining material from a stomach of a patient using theassembly according to claim 2, wherein the patient is fitted with agastrostomy tube (305) in fluid communication with the stomach and thegastrostomy tube (305) is configured with a skin port valve (310) toalternatively allow and prevent passage of fluid between the stomach andthe gastrostomy tube (305), the method comprising: (a) connecting thesecond tube (203) to the skin port valve (310), to allow fluidcommunication between the second tube (203) and the gastrostomy tube(305); (b) opening the skin port valve (310); and (c) allowing passageof the material from the stomach through the gastrostomy tube (305),through the branched lumen (220), and out the first port (205).
 18. Amethod for infusing fluid into the stomach using the assembly accordingto claim 15, wherein the patient is fitted with a gastrostomy tube (305)in fluid communication with the stomach and the gastrostomy tube (305)is configured with a skin port valve (310) to alternatively allow andprevent passage of fluid between the stomach and the gastrostomy tube(305), the method comprising: (a) connecting the second tube (203) tothe skin port valve (310), to allow fluid communication between thesecond tube (203) and the gastrostomy tube (305); (b) occluding thefirst tube (204) to prevent the passage of fluid therethrough; (c)opening the skin port valve (310); and then (d) forcing fluid from thefluid reservoir (500), causing fluid to flow, in turn, from the fluidreservoir (500), through the one-way valve (103), through the connector(201), through the second tube (203), through the open skin port valve(310), through the gastrostomy tube (305), and into the stomach.